NCT07434505 · Mayo Clinic
Comparison of Iliac Crest Marrow vs. Proximal Tibia Avitus® Bone Graft
What this study is about
The purpose of this research is to provide comparative data about the Avitus product and its equivalence to other Bone Marrow Aspirate (BMA) harvesting techniques.
View original scientific description
The purpose of this research is to provide comparative data about the Avitus product and its equivalence to other Bone Marrow Aspirate (BMA) harvesting techniques.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient must be 18 years of age or older.
- Patient must be able and willing to sign the IRB approved informed consent.
- Patient must consent to preoperative knee and pelvis radiographs to confirm no issue at harvest location.
- Patient has indication for autograft bone harvest (undergoing any ankle or hindfoot fusion, complex mid and forefoot fusions requiring graft supplementation, treatment of fuse and fracture nonunions)
- Patient is indicated for proximal tibia autograft harvest and iliac crest BMA (e.g. no hx bilateral TKAs or previous iliac wing trauma bilaterally).
- Patient is skeletally "mature" and presents with no concern for osteopenia/osteoporosis.
- Patient has sufficient volume of harvest material for study inclusion (minimum of 10 ml of cancellous bone graft plus 10 ml fluid pressed out from cancellous bone portion)
- Patient must speak English or have access to sufficient translator.
Exclusion criteria
- Patient is 70 yrs of age or older.
- Patient is unwilling or unable to give consent or comply with study protocol.
- Patient has any condition, which in the judgement of the Investigator, places the patient at undue risk or interferes with the study.
- Patient has mental or neurological disorder that will not allow for proper informed consent.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
- Patient has any condition, which in the judgement of the Investigator, may chemically skew bone marrow. This may include but is not limited to the following:
- Undergoing chemotherapy radiation,
- Bone marrow transplant
- Infection at the donor sites
- Organ transplant on antirejection meds
- Usage of anti-rheumatologic drugs
- Chronic steroid usage
- Myelodysplastic Syndromes
- Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.
Where
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations